SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS

Plate, Cranioplasty, Preformed, Non-alterable

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Patient Specific Cranial/craniofacial Implants.

Pre-market Notification Details

• Device ID: K033868
• 510k Number: K033868
• Device Name: SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS
• Classification: Plate, Cranioplasty, Preformed, Non-alterable
• Applicant: SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301
• Contact: Lisa M Boyle
• Correspondent: Lisa M Boyle; SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301
• Product Code: GXN
• CFR Regulation Number: 882.5330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-12-12
• Decision Date: 2004-06-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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